A Study to Assess the Disease Control of Moderate to Severe Atopic Dermatitis in Male and Female Participants of Atleast 12 Years Old Receiving Dupilumab Injections in Gulf Countries (AD-impaCT)

Sanofi

Status: Completed

Conditions: Dermatitis Atopic

Study type: Observational

Funder types: Industry

Identifiers

NCT05214326

U1111-1269-6618 (Registry Identifier)

OBS17399

Details and patient eligibility

About

Primary objective:

To assess the disease control of moderate to severe atopic dermatitis in patients aged 12 years and above treated with dupilumab therapy using Atopic Dermatitis Control Tool (ADCT) after 24 weeks of treatment.

Secondary objectives:

• To figure the proportion of patients with reduction of ADCT score by 5 points after 4, 12, and 24 weeks of treatment.
• To figure the proportion of patients with ADCT score less than 7 at weeks 4, 12, and 24.
• Assess the effectiveness of dupilumab in moderate to severe atopic dermatitis (AD) patients, using the severity score as routine practice SCORing Atopic Dermatitis (SCORAD).
• To describe comorbidities related to type 2 inflammation.
• To characterize the safety profile of dupilumab in the local Gulf population.
• To evaluate treatment satisfaction in the local Gulf population.

Full description

24 weeks

Enrollment: 187 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having moderate to severe atopic dermatitis:

  • Moderate atopic dermatitis is defined at screening and baseline as i) Atopic dermatitis body surface area (BSA) involvement ≥10%; and ii) Pruritus numerical rating scale (NRS) ≥3, Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline, Investigator's Global Assessment (IGA)=3, or SCORing Atopic Dermatitis (SCORAD) is between 25 and 50.
  • Severe atopic dermatitis is defined at screening and baseline as i) Atopic dermatitis BSA involvement ≥10%; ii) Eczema Area and Severity Index (EASI) score ≥20; iii) Investigator's Global Assessment (IGA) score = 4, or SCORAD ≥50.

• Initiating dupilumab therapy within 30 days of enrollment, according to the treating physician's decision independently of study participation.

• Participants and/or his legally approved representatives (LAR, in case of minor subject) agrees to sign an informed consent or an assent.

• Age of 12 years or above.

Exclusion criteria

• Participation in another trial.
• Pregnancy or lactating or planning/intending to be pregnant in the next 6 months.
• Presence of active chronic or acute infection requiring systemic treatment
• Diagnosed active endoparasites infection, or suspected high risk of infection.
• Human immunodeficiency virus (HIV), hepatitis B or C, malignancy, or other concomitant illnesses.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Trial design

187 participants in 1 patient group

Participants with moderate to severe atopic dermatitis

Description:

Participants initiating dupilumab therapy within 30 days of enrollment, according to the treating physician's decision independently of study participation.